Frampton James E, Wagstaff Antona J
Adis International Limited, Auckland, New Zealand.
Drugs. 2003;63(12):1229-43; discussion 1245-6. doi: 10.2165/00003495-200363120-00003.
Alemtuzumab is an unconjugated, humanised, monoclonal antibody directed against the cell surface antigen CD52 on lymphocytes and monocytes. In noncomparative phase I/II studies in patients with B-cell chronic lymphocytic leukaemia (B-CLL) relapsed after or refractory to alkylating agents and fludarabine, intravenous (IV) administration of alemtuzumab 30 mg/day three times weekly for up to 12 weeks was associated with overall objective response (OR) rates of 21-59%. Combining alemtuzumab with fludarabine resulted in ORs >80%. In noncomparative studies in patients with previously untreated B-CLL, subcutaneous (SC) administration of alemtuzumab alone, or IV in combination with fludarabine, was highly effective, achieving OR rates of around 90%. IV alemtuzumab was active in patients with chemotherapy-resistant/relapsed T-cell prolymphocytic leukaemia, with reported OR rates of 24-76%. Alemtuzumab has been incorporated in novel conditioning regimens designed to facilitate stem cell transplantation in haematological malignancies. Adverse events with alemtuzumab are predictable and manageable. 'First-dose' flulike symptoms, frequently seen after IV infusion, can be managed by (pre)medication and minimised by dose escalation (or SC injection). Anti-infective prophylaxis is mandatory. Cytopenias are transient, although red blood cell and platelet support may be required.
阿仑单抗是一种非共轭的人源化单克隆抗体，靶向淋巴细胞和单核细胞表面的抗原CD52。在针对烷化剂和氟达拉滨治疗后复发或难治的B细胞慢性淋巴细胞白血病（B-CLL）患者的非对照I/II期研究中，静脉注射阿仑单抗30mg/天，每周3次，持续12周，总体客观缓解（OR）率为21%-59%。阿仑单抗与氟达拉滨联合使用，OR率>80%。在针对既往未治疗的B-CLL患者的非对照研究中，单独皮下注射阿仑单抗或与氟达拉滨联合静脉注射均非常有效，OR率约为90%。静脉注射阿仑单抗对化疗耐药/复发的T细胞幼淋巴细胞白血病患者有效，报道的OR率为24%-76%。阿仑单抗已被纳入旨在促进血液系统恶性肿瘤干细胞移植的新型预处理方案中。阿仑单抗的不良事件是可预测和可管理的。静脉输注后常见的“首剂”流感样症状可通过（预）用药进行处理，并通过剂量递增（或皮下注射）将其降至最低。必须进行抗感染预防。血细胞减少是短暂的，尽管可能需要红细胞和血小板支持。
